Clearance Summary
VSCAN WITH DUAL PROBE received FDA 510(k) clearance under submission number K140693, sponsored by Ge Medical Sysyems Ultrasound & Primary Care Diagn. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2014-05-16.
- Submission: K140693
- Applicant / Sponsor: Ge Medical Sysyems Ultrasound & Primary Care Diagn
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1550
- Decision date: 2014-05-16
Classification & Regulation
This clearance is catalogued under FDA product code IYN and 21 CFR 892.1550, within the Radiology review panel as a Class II device.